FDA Approves Samsung Bioepis’ Humira Biosimilar

Humira contains Adalimumab, a drug that is recommended for the treatment of rheumatoid arthritis.

FDA Approves Samsung Bioepis

On Tuesday, the U.S. Food and Drug Administration (FDA) approved Samsung Bioepis’ biosimilar to Humira, a blockbuster drug for rheumatoid arthritis manufactured by AbbVie Inc.

Samsung Bioepis, a South Korean pharmaceutical company, develops Hadlima, which is biosimilar to Humira.

Hadlima comes with a boxed warning. The FDA warned about the potential risk of serious infections, including bacterial sepsis and tuberculosis. Humira also comes with a black box warning.

Merck & Co Inc. will be commercializing the drug in the United States.

In October, the FDA approved a generic version of Humira developed by Novartis. In Europe, Humira has already been facing stiff competition for generic versions.

Humira is the best-selling prescription medication for rheumatoid arthritis. In the past six years, for AbbVie Inc., the drug has remained the top-earner so far.

In 2018, Humira brought in revenue of nearly $20 billion for AbbVie. In November, AbbVie reduced its forecast for overseas sales of Humira, referring stiff competition in Europe from pharma companies such as Mylan NV and Biogen Inc.